NCT03696329

Bioequivalence Study of Tetrabenazine Tablets 25 mg Under Fasting Conditions

An Open Label, Balanced, Randomized, Two-treatment, Four-period, Two-sequence, Single Dose, Crossover, Fully Replicated Oral Bioequivalence Study of Tetrabenazine Tablets 25 mg of Dr. Reddy's Laboratories Limited, India Comparing With XENAZINE® (Tetrabenazine) Tablets 25 mg of Lundbeck Inc., USA in Healthy, Adult, Human Subjects Under Fasting Conditions.

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 48 (actual)
• Sponsor: Dr. Reddy's Laboratories Limited · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

This is an open-label, randomized, four-period, two-treatment, two-sequence, balanced, single dose, crossover, oral bioequivalence study in healthy, adult, human subjects under fasting conditions.

Detailed description

An open label, balanced, randomized, two-treatment, four-period, two-sequence, single dose, crossover, fully replicated oral bioequivalence study of Tetrabenazine Tablets 25 mg of Dr. Reddy's Laboratories Limited, India comparing with XENAZINE® (tetrabenazine) Tablets 25 mg of Lundbeck Inc., USA in healthy, adult, human subjects under fasting conditions.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Tetrabenazine Tablets 25 mg

Timeline

• Start date: 2015-10-01
• Primary completion: 2015-11-01
• Completion: 2015-11-01
• First posted: 2018-10-04
• Last updated: 2018-10-18

Locations

1 site across 1 country: India